10+ years of biopharma experience: CDMO selection, plasmid and viral vector mfg, AAV process dev, analytical dev, regulatory strategy/writing, bioanalytical method dev for clinical-stage cell tx products.
CMC
Regulatory
Nonclinical
Deb is passionate about bringing new treatments to patients with unmet medical needs and joins Dark Horse Consulting with over 10 years of experience in the pharmaceutical and biotech industry. Deb was most recently Director, Regulatory CMC at Nuevocor, a gene therapy company developing novel treatments for genetic cardiomyopathies. There, she led CDMO selection and oversaw outsourcing of plasmid and viral vector manufacturing for Nuevocor’s first GMP batch. She built a cross-disciplinary team to bring in-house expertise in AAV process development as well as analytical capabilities for preclinical, CMC and clinical product-specific assays. She further crafted the strategy for CMC leading to pre-IND and was lead author for the CMC section of the pre-IND.
Prior to this, Deb was a Principal Scientist at Tessa Therapeutics, a clinical-stage CAR-T cell therapy company. In this role, she collaboratively led the development of bioanalytical methods (including genomic, cell-based, flow cytometry and ELISpot assays) for lot release, characterization, and biomarker studies of clinical-stage cell therapy products. She provided scientific direction for assay transfer and validation to outsourced partners or the in-house Quality Control lab, contributed to CMC analytical regulatory strategy and authored regulatory submissions for Tessa’s pipeline programs. She also collaborated with the process team to improve the CAR-T manufacturing process.
Deb made her first foray into industry as Senior Scientist at Merck & Co., Inc. where she developed biomarker assays for preclinical and clinical programs. She then moved on to novel target identification and validation in various therapeutic areas (immuno-oncology, respiratory, cardiometabolic and neuroscience) across different drug modalities. As project lead, she was responsible for communicating program strategy, preliminary competitive intelligence, business justification and Go/No-Go decisions to stakeholders. To advance these programs, she engaged local academics and clinicians, and leveraged external innovation opportunities in preclinical models, translational medicine and clinical development.
Nuevocor
Director (Regulatory CMC)
Tessa Therapeutics
Principal Scientist (Product Development/Analytical Science)
Merck
Senior Scientist, Product Development
Senior Scientist, Molecular Biomarkers
Yale University School of Medicine
Postdoctoral associate
Visiting Assistant of Research
Deb has a Ph.D. in Molecular Microbiology and Microbial Pathogenesis from Washington University in St. Louis, and later followed up on her graduate work as post-doc at Yale University, where she studied the evolution and regulation of antibiotic resistance in bacteria using a wide variety of cellular and molecular techniques, in vivo mouse models and bioinformatics tools.
